Senior Quality Assurance Specialist Pharma

Industry: Pharmaceutical / Biotechnology

We are seeking an experienced Senior Pharma QA Specialist to support Quality Assurance and Compliance activities within a highly regulated GMP environment.

Key Responsibilities:

• Provide senior-level QA oversight for GMP manufacturing and quality operations.
• Review and support deviations, investigations, CAPAs, change controls, and risk assessments.
• Ensure compliance with FDA, EU GMP, and applicable regulatory requirements.
• Support quality systems, validation, documentation, and data integrity activities.
• Support internal and regulatory audits and inspection readiness.
• Partner with Manufacturing, QC, Validation, Engineering, and other cross-functional teams.
• Serve as a QA SME and provide guidance on quality and compliance requirements.

Required Qualifications:

• 8 10+ years of hands-on QA experience in pharmaceutical, biotechnology, or similarly regulated industries.
• Strong GMP/cGMP and pharmaceutical quality systems knowledge.
• Experience with deviations/investigations, CAPA, change control, risk management, and audits.
• Strong understanding of data integrity and regulatory compliance.
• Bachelor's degree in Life Sciences, Chemistry, Engineering, Pharmacy, or a related scientific discipline preferred.
• Strong communication, documentation, problem-solving, and collaboration skills.

Travel Requirement:

• Must be available to travel to Limerick, Ireland as required.
• Each visit may require approximately 2 weeks onsite.